Commissioning and Qualification (C&Q) Engineer
Core
Lead and support the planning, execution, and documentation of commissioning, qualification, and airflow visualization (smoke studies) for pharmaceutical cleanrooms, isolators, and critical HVAC utilities to ensure strict regulatory compliance.
Role type
Commissioning and Qualification (C&Q) Engineer
Builds
Pharmaceutical cleanrooms, isolators, and critical HVAC utilities
Domain
Pharmaceutical manufacturing / HVAC systems
Required skills
cGMP compliance, HVAC system validation, airflow visualization (smoke studies), HEPA filter integrity testing, pressure differential verification, protocol authoring (URS, DQ, IQ, OQ, PQ), deviation investigation, change control management, P&ID interpretation
Preferred skills
Strategic agility, action-oriented execution, stakeholder coordination with QA and vendors
Technologies
HVAC systems, Air Handling Units (AHUs), HEPA filters, smoke visualization tools
Responsibilities
Commission, qualify, and validate facilities, utilities, and equipment; Draft and execute commissioning and qualification protocols; Plan, record, and analyze airflow visualization studies; Inspect HVAC systems and perform HEPA filter integrity testing; Author validation summary reports and manage change controls; Coordinate with Quality Assurance and third-party vendors to resolve field issues
Seniority
Mid-level, hands-on IC